Rollover Protocol for Prior SU011248 Protocols

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00798889

First received: November 25, 2008

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Results First Received: December 13, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Solid Tumors
Intervention:	Drug: Sunitinib

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from prior studies in which they received sunitinib.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Sunitinib	Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.

Participant Flow: Overall Study

	Sunitinib
STARTED	314
Treated	311
COMPLETED	0
NOT COMPLETED	314
Adverse Event	53
Protocol Violation	2
Withdrawal by Subject	31
Lost to Follow-up	1
Lack of Efficacy	213
Decision of Sponsor	11
Enrolled, Not treated	3

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Sunitinib	Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.

Baseline Measures

	Sunitinib
Number of Participants [units: participants]	311
Age [units: Years] Mean ± Standard Deviation	58.5 ± 11.62
Gender [units: Participants]
Female	113
Male	198

Outcome Measures

1. Primary:

Duration of Treatment [ Time Frame: Baseline up to Day 28 after last dose of study treatment ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00798889 History of Changes
Other Study ID Numbers:	A6181030
Study First Received:	November 25, 2008
Results First Received:	December 13, 2012
Last Updated:	December 13, 2012
Health Authority:	United States: Food and Drug Administration

To Top